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Clinical Trial News

AOH1996: Novel Cancer Drug Selectively Targets Tumors, Spares Healthy Cells in Preclinical Studies

  • AOH1996, a novel drug developed by City of Hope researchers, targets a unique form of PCNA present in cancer cells, disrupting tumor growth.
  • Preclinical studies demonstrate AOH1996's efficacy across 70 cancer cell lines, including breast, prostate, lung, and ovarian cancers, without harming healthy cells.
  • Currently in Phase 1 clinical trials, AOH1996 is being evaluated for safety and efficacy in humans, offering a potential breakthrough in personalized cancer treatment.
  • The drug's unique mechanism of action allows it to be used alone or in combination with other cancer therapies, showing promising results without significant toxicity.

ESMO 2024: Novel Agents and Combinations Show Promise in Urothelial and Renal Cell Carcinomas

• Belzutifan demonstrates sustained progression-free survival benefit compared to everolimus in previously treated renal cell carcinoma patients. • Belzutifan combined with cabozantinib shows a confirmed objective response rate of 30.8% in patients with advanced clear cell renal cell carcinoma. • Disitamab vedotin, targeting HER-2, shows a response rate of approximately 50% in previous phase 2 trials for urothelial carcinoma. • Trastuzumab deruxtecan receives FDA accelerated approval for HER-2 positive solid tumors, including bladder cancer, based on a 39% objective response rate.

Clinical Trial Shows Promise for Maralixibat in Treating ALGS-Related Cholestatic Pruritus

A phase IIb clinical trial, ICONIC, evaluated the safety and efficacy of maralixibat in children with Alagille Syndrome (ALGS), showing significant improvements in serum bile acid (sBA) levels and pruritus severity. The study, involving 31 patients aged 1 to 18 years, demonstrated maralixibat's potential as a treatment for cholestatic pruritus in ALGS patients, with notable reductions in sBA and improvements in quality of life measures.

NKT2152 Shows Promise as HIF-2α Inhibitor in Advanced Clear Cell Renal Cell Carcinoma

  • Data from an ongoing phase 1/2 study reveals that NKT2152, an oral HIF-2α inhibitor, exhibits strong anti-tumor activity in heavily pretreated advanced clear cell renal cell carcinoma patients.
  • The study's findings suggest that blocking HIF-2α is a clinically meaningful approach to interacting with the disease biology of clear cell renal cell carcinoma.
  • Further research is needed to identify which patients are most likely to respond to NKT2152, understand the mechanisms of resistance, and determine optimal combination strategies.

A Study of NKT2152, a HIF2α Inhibitor, in Patients with Advanced Clear Cell Renal Cell Carcinoma

NCT05119335Active, Not RecruitingPhase 1
NiKang Therapeutics, Inc.
Posted 10/26/2021

Real-World Study Confirms Comparable Outcomes with Infliximab Biosimilar CT-P13 in Rheumatoid Arthritis

  • A real-world study evaluating the infliximab biosimilar CT-P13 (Inflectra) in rheumatoid arthritis (RA) patients showed stable disease activity in those switching from reference infliximab.
  • Patients switching from other biologics or DMARDs to CT-P13 experienced improvements in disease activity, suggesting potential benefits in specific patient subgroups.
  • The study provides insights into the effectiveness of CT-P13 in routine clinical practice, potentially reducing hesitation among clinicians regarding its use in RA.
  • Findings suggest that real-world outcomes of CT-P13 treatment align with efficacy outcomes observed in clinical trials, supporting its use as a comparable alternative.

Gan & Lee's Once-Weekly Insulin GZR4 Shows Promising Phase I Results in Type 2 Diabetes

• Gan & Lee's GZR4, a novel once-weekly insulin analog, demonstrated favorable safety and tolerability in healthy subjects in a Phase Ia clinical study. • Phase Ia study results suggest GZR4 maintains a stable glucose-lowering effect for up to one week with a single administration. • In a Phase Ib study involving T2DM patients, GZR4 exhibited improvements in fasting blood glucose and HbA1c, outperforming insulin degludec. • GZR4 demonstrated good safety and tolerability in T2DM patients, with no serious adverse events reported during the Phase Ib trial.

Ipilimumab/Nivolumab Combo Improves Survival in Non-Clear Cell Renal Cell Carcinoma

• The SUNNIFORECAST trial demonstrated that ipilimumab plus nivolumab significantly improved the 12-month overall survival rate in patients with non-clear cell renal cell carcinoma (nccRCC). • Patients receiving the combination therapy showed an 86.9% overall survival rate at 12 months, compared to 76.8% with standard of care (SOC) treatments. • The combination therapy also showed a longer median overall survival time among papillary high-risk patients, with a consistent safety profile. • These findings suggest ipilimumab/nivolumab may become a new standard of care for nccRCC, warranting further analysis and international cooperation due to the rarity of the disease.

Randomized Phase-II Study of Nivolumab Plus Ipilimumab vs. Standard of Care in Untreated and Advanced Non-clear Cell RCC

NCT03075423Active, Not RecruitingPhase 2
Goethe University
Posted 11/1/2017

UBC Okanagan Researchers Develop iValve: A Novel Mechanical Heart Valve

  • Researchers at UBC Okanagan have developed the iValve, a mechanical heart valve combining the durability of mechanical valves with the performance of tissue valves.
  • The iValve is specifically designed for high-heart-rate applications, making it suitable for pediatric patients, addressing a long-standing challenge in cardiology.
  • The new valve demonstrates improved hemodynamic performance, potentially reducing the need for anticoagulant therapy and improving patients' lifestyles.
  • The iValve, designed and built in Canada, has shown promising results in mechanical lab tests and is advancing towards animal and clinical trials.

Enfortumab Vedotin Shows Efficacy in Advanced Urothelial Carcinoma Outside Clinical Trials

  • Enfortumab vedotin (EV) combined with pembrolizumab demonstrates a high disease control rate in advanced urothelial carcinoma (aUC) patients outside clinical trials.
  • Alterations in KMT2D and TP53 genes are associated with shorter progression-free survival (PFS) and overall survival (OS) in patients treated with EV/P.
  • Baseline neuropathy does not lead to inferior outcomes with EV treatment, suggesting comorbidities should not preclude its use with careful monitoring.
  • The UNITE study provides real-world evidence supporting the use of enfortumab vedotin, both as monotherapy and in combination, for aUC patients with diabetes or neuropathy.

Remote Clinical Trials Show Significant Growth in Oncology and Cardiovascular Research

  • Remote clinical trials are increasingly adopted in the United States, driven by technological advancements and the need for patient-centric methodologies.
  • Oncology research benefits significantly from remote trials, improving patient recruitment and enabling real-time data collection for treatment efficacy and safety.
  • In cardiovascular research, remote trials allow continuous monitoring of vital signs and adherence to treatment protocols from patients' homes, enhancing data collection.
  • These remote methodologies transform data collection and analysis, providing comprehensive insights into new cardiovascular drugs and interventions in real-world settings.

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